A Randomized, Phase 1, Double-blind, Single and Multiple-Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OMS1620 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The goal of this study is to explore the safety, drug concentrations and effects on adrenal gland hormones after a single dose or multiple doses of OMS1620 in healthy participants. In addition, the effect of food on drug concentrations will also be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive) and weight ≥45.0 kg
- •Females must be either postmenopausal, surgically sterile or consistently use highly effective methods of contraception from 30 days prior to Day -1 until at least 30 days after the end of the study.
- •Females must not be pregnant or lactating
- •Males participants who are sexually active with female partners who are females of childbearing potential must use at least two medically effective methods of contraception from Screening through 90 days after the last dose of study drug
- •Medically healthy with no significant medical history, physical examination, laboratory, vital signs, or ECG findings, as deemed by the Investigator or qualified designee
排除标准
- •Use of systemic glucocorticoid therapies within 3 months prior to Screening or use of local glucocorticoid therapies (nasal, topical or inhaled) within 1 month prior to Screening
- •Use of mineralocorticoid therapies within 3 months prior to Screening
- •Current use of oral hormonal contraceptives. Extended cycle (e.g., ≥3 month) injectable, or implantable hormonal contraceptives are permissible, provided the cycle will not end during the conduct of the study
- •Any other condition or prior therapy, that, in the opinion of the Investigator, interferes with the participant's ability to safely complete the study or adhere to study requirements
研究组 & 干预措施
Single Ascending Dose (SAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given as a single dose.
干预措施: OMS1620 (Drug)
Single Ascending Dose (SAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given as a single dose.
干预措施: Placebo (Drug)
Multiple Ascending Dose (MAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given in multiple doses.
干预措施: OMS1620 (Drug)
Multiple Ascending Dose (MAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given in multiple doses.
干预措施: Placebo (Drug)
Food Effect (FE)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given as a single dose on two separate occasions, once while fasted and once with a high-fat meal.
干预措施: OMS1620 (Drug)
结局指标
主要结局
Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
时间窗: From Day 1 to approximately day 25
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma
时间窗: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma
时间窗: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
次要结局
- Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)(enrollment to approximately Day 25)
- Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma(Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD))
- Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma(Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD))